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A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.

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Servier Protocol Code: CL1-95029-002 Sponsor: Servier Bio-Innovation LLC Clinicaltrials.gov Identifier: NCT06116136 EudraCT Number: 2023-507995-33

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 52 locations

Study description

The study is needed to test a new drug called S095029 in combination with an approved drug called pembrolizumab in patients with stomach cancer or gastroesophageal junction cancer.  The gastroesophageal junction is where the stomach meets the oesophagus (the tube that connects the throat to the stomach).

Normally, the immune system protects the body from foreign substances and fights diseases, including cancer. However, cancer cells can find ways to escape from immune cells, allowing them to survive and spread.

S095029 is an antibody, a protein that helps the body’s immune system fight cancer cells.

Researchers hope that by combining S095029 with other drugs like pembrolizumab, the treatment will be more effective against cancer cells. Pembrolizumab is another type of antibody. It helps immune cells by blocking PD-1, a protein that cancer cells use to escape immune system.

The main goal of the study is to see how safe S095029 is when used with pembrolizumab in participants with stomach or gastroesophageal junction cancer that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic). The study will also check how well the combination of these two drugs works.

Official title: Open Label, Non-randomized, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of S095029 (Anti-NKG2A Antibody) as a Part of Combination Therapy in Participants With Locally Advanced and Unresectable or Metastatic MSI-H/dMMR Gastro-esophageal Junction /Gastric Cancer
Conditions
MSI-H/dMMR Gastroesophageal-junction Cancer MSI-H/dMMR Gastric Cancer
Interventions / Treatments
  • S095029
  • pembrolizumab 200 mg (KEYTRUDA ®)
Other study id numbers
  • CL1-95029-002

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be adults aged 18 or older.
  • Have unresectable or metastatic stomach or gastroesophageal junction cancer.
  • Be generally healthy with well-functioning bone marrow (the spongy tissue inside bones where blood cells are made), liver and kidneys.

 

Participants cannot take part in the study if:

  • They have previously received a treatment that is similar to the study drug.
  • They have received any other treatments for their cancer in the 4 weeks before starting the study.
  • They have received radiation therapy in the 2 weeks before starting the study.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: S095029 and pembrolizumab
Intervention / Treatment
Drug: S095029

Participants will receive S095029 through infusion (injection given slowly) into a vein every 3 weeks.

Drug: Pembrolizumab (KEYTRUDA ®)

Participants will receive 200 mg of pembrolizumab infusion (injection given slowly) into a vein every 3 weeks.

Keywords

Provided by Servier
Anti-NKG2A S095029 pembrolizumab MSI-H/dMMR Gastric cancer Gastroesophageal-junction cancer
Additional Relevant MeSH Terms Glioma
Stomach Neoplasms